This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years. The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. The total time of participation in the clinical trial will be 90 weeks.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body Mass Index (BMI) between 18 to 35 kg/m\^2 inclusive at screening
* Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the National Institute on Aging - Alzheimer's Association (NIA - AA) research framework
* Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5
* Positive amyloid PET scan based on a cut-off of ≥24 CL units
* Availability of a person (referred as a "study partner" throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant's cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant's cognitive and functional abilities; (b) is in sufficient good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study
* In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to baseline
Exclusion C…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing RO7269162 in people who are at risk for or at the very early, prodromal stage of Alzheimer's — how would my doctor determine whether my current stage actually matches what this study was designed for?
2Since this is a Phase 2 trial, what does that mean for how much is already known about whether RO7269162 is safe, and what kinds of adverse events showed up often enough that the study is specifically tracking them as a primary outcome?
3The trial uses amyloid PET scans to measure changes in brain amyloid as one of its main goals — would I need to undergo multiple PET scans as part of this, and are there any practical or health considerations around that level of imaging?
4The study is listed as active but no longer recruiting — does that mean results or safety data might be available soon, and could my doctor find out what has been observed so far before we decide on a treatment direction?
5Given that this trial focuses on people before a full Alzheimer's diagnosis, are there standard-of-care options or other trials my doctor would recommend I consider first, or alongside, this kind of early-stage intervention study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: up to week 72
2
Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan